The need for this invention arises from surgical practice, particularly surgical practice using laparoscopic instruments involving small incisions, with a television camera inserted in one of the incisions to view the field of the operation inside the patient and surgical instruments inserted in other incisions and manipulated from outside the patient""body using a TV screen visualization, usually enlarged, to guide the work.
Anything that can reduce the number of steps to be performed in such an operation can markedly reduce the stress, both on the patient and on the doctor. Surgeons performing such operations are under considerable stress because remote manipulation using TV for visualization, rather than seeing the site of the operation directly requires the learning of a great many techniques that are radically different from those performed when the surgical site is open to view. These include indirect hand-eye coordination, and cooperation between surgeons to place and secure sutures.
The placing of sutures during a laparoscopic procedure typically requires two surgeons to cooperate in a multi-step process performed with multiple surgical instruments to manipulate the needle and the suture and pass it back and forth from one to the other, cooperation in tying the knot, etc. This invention arose from experiencing the difficulty of such manipulations.
Additionally, coagulation and clips, such as xe2x80x9chemo clipsxe2x80x9d, have reduced many of the needs for endoscopic suturing. However, when one considers the need to suture repair ovaries, uterus, seromuscular defects, enterotomies, systomies, pelvic defects, various suspension procedures i.e. vaginal vault and sacrospinous, one must realize there is a continual need to keep the art of endoscopic suturing to the forefront. The endoscopic suturing must be so simple that it be easily learned, hence easily remembered. The learning curve in endoscopic suturing is inversely proportional to the number of steps required to do the suturing; i.e. the fewer steps required the easier it is to learn and teach the endoscopic suturing technique. It is the purpose of the present invention to provide a structure, which makes it easier to learn and teach an endoscopic suturing technique.
U.S. Pat. No. 5,413,585 and allowed application, Ser. No. 09/089,916, filed Jun. 3 1998 and assigned to the assignee of the present application, are believed, presently, to be the closest prior art references.
The present invention is an integrally molded, one-piece, combination suture thread and crimpable lock opening, and is preferably used with a suture needle. A least one crimpable ring is integrally molded with a mono-filament suture thread so that a crimpable opening is presented in the suture thread. The suture thread and crimpable opening is made of a material that is easily molded, yet is strong when cured. Further, the material must be biologically compatible with the surgical application in which it is to be used. The major consideration given to the type of material chosen is the tolerance of the human body to fairly long exposure to the presence of this material. Materials that the human body can tolerate, or an animal body can tolerate should this device be used on non-humans, should be chosen. Examples of suitable material include polygalaxon and DEXON monofiliment. Accordingly, the needle may, after passing through the desired tissue to be sutured, be drawn through the crimpable lock opening a distance suitable to the surgeon making the stitch, and then the crimpable lock opening is crimped with a crimping tool known in the surgical art, thereby locking the suture thread in place without the necessity of tying a knot. In the preferred embodiment, the molded suture and crimpable lock opening is integrally formed, while the needle is attached to the suture thread either permanently or impermanently in a known way, as for example xe2x80x9cpop offxe2x80x9d needles. The crimpable lock opening is of a diameter slightly larger than the diameter of the suture thread, so that the suture thread may initially pass through the opening. When the medical practitioner desires to create a securement at a location along the suture thread, the crimpable ring surrounding and forming the lock opening, is crimped around the diameter of the suture thread.
Alternatively, the present invention may be described as a molded, one-piece suture having a plurality of laterally spaced, integrally molded, crimpable openings along the suture thread length.
In another embodiment, the mono-ply, integrally molded suture and crimpable openings of the previously disclosed embodiments may be covered with a plurality of filaments to form a plaited, multi-ply structure.
In yet another embodiment, an integrally molded suture thread may include a plurality of crimpable openings wherein the openings may be disposed in a superposed configuration. A stacked or superposed configuration allows an individual crimpable opening to be accessed and crimped independently of another, while allowing the practitioner to place multiple sutures in the same vicinity.
In still another embodiment, the suture thread, having a plurality of superposed crimpable openings, may be covered with a plurality of filaments to form a plaited, multi-ply structure.